Development of vaccines: from discovery to clinical testing

Development of Vaccines: From Discovery to Clinical Testing outlines the critical steps, and analytical tools and techniques, needed to take a vaccine fromdiscovery through a successful clinical trial. Contributions from leading experts in the critical areas of vaccine expression, purification, formulation, pre-clinical testing and regulatory submissions make this book an authoritativecollection of issues, challenges and solutions for progressing a biologic drug formulation from its early stage of discovery into its final clinical testing. A section with details and real-life experiences of toxicology testing and regulatory filing for vaccines is also included. INDICE: Section 1. Immunogen Design. Ch 1. Microbial Vaccines Design: The Reverse Vaccinology Approach (Roberto Rosini, Michèle A. Barocchi, Rino Rappuoli). Ch 2. Design and Development of Recombinant Vaccines with Viral Properties (Gerd Lipowsky, Martin F. Bachman). Ch 3. Tools for Vaccine Design: Prediction and Validation of Highly Immunogenic and Conserved Class II Epitopes and Development of Epitope-Driven Vaccines (Anne S. De Groot, Matthew Ardito, Ryan Tassone, Joseph Desrosiers, Paul Knopf, Leonard Moise, William Martin). Section2. Vaccine Platforms. Ch 4. Virus Like-Particle Vaccines advantages and Challenges (Ted M. Ross, Nitin Bhardwaj, Hermancia E. Eugene, Brendan M. Giles, Sean P. McBurney, Shannan L. Rossi, Kirsten Schneider-Ohrum, Xian-Chun Tang). Ch 5. Design Platforms of Nanocapsules for Human Therapeutics or Vaccines (Masaaki Kawano, Li Xing, Kit S. Lam, Hiroshi Handa, Tatsuo Miyamura, Susan Barnett, Indresh K. Srivastava and R. Holland Cheng). Ch 6. Designing Immunogens for Vaccine Development in Reference to HIV (Aemro Kassa, Zohar Biiron-Soreki, PampiSarkar, and Indresh K. Srivastava). Ch 7. Expression and Purfication of Recombinant Proteins for Vaccine Applications (Carlo Zambonelli, Deeann Martinez-Guzmann, and Indresh K. Srivastava). Ch 8. DNA Vaccines for Infectious disease (Samuel Stephenson, Manmohan Singh, Indresh K. Srivastava). Ch 9. Developing Stable Cell Lines for the Production of Vaccine Antigens (Xiaotian Zhong, Zhijian Lu, Richard Zollner, Jimin Zhang, Emily Braunstein, Narender Kalyan, and Maninder Sidhu). Section 3. Characterization of Immunogens. Ch 10. Spectroscopy of Vaccines (C. Russell Middaugh, Sangeeta B. Joshi). Ch 11. Biophysical Characterization of Protein Antigens Within Vaccine Formulations (Padma Malyala, Derek OHagan, Manmohan Singh). Section 4. Formulation optimization and stability evaluation. Ch 12. Structural Characteristics Predict the Stability of HIV (Zohar Biron, Yide Sun, Elaine Kan, Jeanne Flandez, Michael Franti, Jeffrey Ulmer, Susan Barnett, Indresh K. Srivastava). Ch 13. Selection of Optimal Adjuvants and Product Factors that Affect Vaccine Immunogenicity (Wei Wang, Manmohan Singh). Ch 14. Lyophilization and Stabilization of Vaccines (James Chesko, Chris Fox, Tim Dutill, Thomas Vedvick, Steve Reed). Ch 15. Effect of Buffers and Stabilizers on Vaccine Stability and Efficacy (Shireesh P. Apte, Sydney Ugwu).Section 5. Clinical and manufacturing issues. Ch 16. Selection of Final Containers (Luis Baez, Adrian Distler). Ch 17. From The Lab to the Clinic: Filing aPhase I IND for an Investigational Vaccine (Kenneth G. Surowitz).

• ISBN: 978-0-470-25637-4
• Editorial: John Wiley & Sons
• Encuadernacion: Cartoné
• Páginas: 480
• Fecha Publicación: 24/06/2011
• Nº Volúmenes: 1
• Idioma: Inglés